Supporting funding applications and ethical review with the EDA

Whenever animal research is planned a harm benefit analysis needs to be completed to ensure that the benefits from the research outweigh the likely harms to the animals. Part of the harm benefit analysis includes a review of the proposed experimental design. If an experiment is not designed to yield reliable results the benefits of the science cannot be realised.
 
The EDA helps researchers design rigorous experiments by providing bespoke feedback on the study design and statistical analysis plans. The visual representation of the experiment and the detailed information in the diagram, provide funders and ethical review boards with greater clarity, helping to inform their decision making and supporting their commitment to rigorous science.

Major organisations recognise the value of the EDA and recommend its use in the preparation of funding or ethical review applications. This includes the MRC, BBSRC, Wellcome Trust, Cancer Research UK, the Academy of Medical Sciences, the Home Office in the UK, the NIH and National Science Foundation in the USA, and the Australian National Health and Medical Research Council. 

 

For committees and panels

The EDA helps with study review

Having a clear idea of what applicants are planning to do is crucial to enable funding and ethical review bodies, or their reviewers/panels, to assess how likely the experiments are to yield reliable results. 

To make this assessment easier funders and ethical review bodies can:

  • Recommend researchers use the EDA to design experiments
Wondering how to translate the application instructions to successfully demonstrate rigor in your application? Learn more about how to prepare a rigorous application with examples of rigor, and resources like the experimental design assistant (EDA), guidance on sample size calculation, authentication plan examples, and more.  NIH, USA – Grants and funding: Resources for preparing your application
  • Request researchers submit an EDA report as part of their application. The report highlights missing information and potential issues with the design, which is especially helpful for panels with limited statistical expertise. 
Researchers can also use the Experimental Design Assistant. This is a free online tool from NC3Rs to help with the design of their experiments. The outputs of this tool can be added as an appendix to the grant application. Wellcome Trust – Use of animals in research policy
Applicants using animals in their research are strongly encouraged to design their experiments using the Experimental Design Assistant (EDA) and use an EDA report to provide the requested methodology and experimental design information. ... Each EDA diagram represents one experiment and only one EDA report can be used per application. The report included could represent the main experiment of the grant, a representative experiment, or the experiment that will use the largest number of animals. Applicants can use the text box (max 300 words) to provide context or add information not contained in the EDA report, for example a justification for not using both sexes. The Panel assessing applications will assume experimental design principles used in the experiment presented in the EDA report (e.g. randomisation to allocate to groups) will be used in all applicable experiments in the grant. The complete report must be included in your application, and the tables and EDA diagram must not be altered on the PDF. If you need to update the EDA report, update the EDA diagram online and generate a new report. NC3Rs – Applicant and Grant Holder Handbook

 

A format to suit your review pipeline/system

To ensure compatibility with various processes, the EDA report is available in two formats, either PDF or URL. Both formats include key information requested by funding and ethical review bodies. The URL version, called a read-only EDA diagram, has an access code for increased security.
 

  PDF EDA report URL EDA report (read-only diagram)

Key experimental design information:

  • Objectives and hypothesis
  • Animal numbers and justification for sample size
  • Steps taken to minimise the effect of bias
  • Primary and secondary outcome measures
  • Planned statistical analysis methods
  • Characteristics of the animals to be used
 Yes Yes
Missing information clearly marked Yes Yes
Experimental design feedback from the EDA that has not been addressed listed Yes Yes
Static image of experiment flow diagram Yes  
Clickable image of experiment flow diagram (further information accessed by clicking different parts of the image)   Yes

 

For applicants

Communicating your experimental plans clearly helps funding bodies and ethical review panels asses the strength of your experiments. Studies that are unlikely to yield reliable results cannot give the scientific benefit required to justify the use of animals. 

The EDA gives you guidance and advice when designing in vivo experiments, helping improve the rigour of your experimental design meaning your results are more likely to be reliable.

Once you have designed your experiment in the EDA and finalised your plans, you can share the output in two different formats:

  • Read-only diagram – an online interactive read-only version of your EDA diagram shared via an unguessable URL.
  • Experimental Design Report – PDF document including an image of your EDA diagram at the end.

Both formats include a table of the key experimental design information essential for your ethics or funding application. This table clearly indicates missing information, so you can address this before submission. Check with your funder or ethical review body which format they accept, if any. If you cannot use either directly in your application, the table present in both can be used as an aide-memoire when preparing your application, to ensure that you have included all necessary information.
 
If you are submitting either the PDF or URL as part of an application, make sure it only represents one experiment. If your application covers a program of work including multiple experiments check if you can submit multiple EDA reports. If you can only submit one EDA report you could choose one that represents the main experiment of the grant/application, a representative experiment or the experiment that will use the most animals. 

Both formats include an image of the experiment to give a visual overview. In the PDF report the image is static, whereas the image in the online read-only diagram is interactive and further detail can be accessed by clicking different parts of the experiment.

The read-only EDA diagram can be shared via an unguessable URL. For security reasons an access code is generated by default when you create a read-only diagram. You need to share both the URL and access code with funders and ethical review bodies to enable them to access your experimental plan.